Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000671167
Ethics application status
Approved
Date submitted
30/04/2019
Date registered
6/05/2019
Date last updated
3/11/2020
Date data sharing statement initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Developmental and Social Benefits of a Classical/Contemporary AllPlay Dance Program for Children with Autism Spectrum Disorder
Scientific title
The Developmental and Social Benefits of a Classical/Contemporary AllPlay Dance Program for Children with Autism Spectrum Disorder
Secondary ID [1] 298005 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder (ASD) 312450 0
Condition category
Condition code
Mental Health 311000 311000 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a classical/contemporary AllPlay Dance program for children with Autism Spectrum Disorder (ASD). It will consist of 8 x 1 hour dance sessions (occurring weekly), followed by a rehearsal session and short performance for family and friends. The program will be informed by our AllPlay Dance resources and strategies that were developed to support the inclusion of children with disabilities in dance (see allplaydance.org.au). The classes will incorporate Laban’s movement principles and will follow the same structure each week (e.g., learning material, making material, shaping material, showing/watching). Each session will be tailored to children with ASD and delivered by dance and disability experts who have prior experience conducting programs of this nature. Between sessions, we will also make available pre-prepared dance videos of the steps and choreography to further support learning.

Elite dancers/buddies will also be recruited to the study to support the children with ASD as they learn new skills and progress through the program. Prior to commencing the program, the elite dancers/buddies will attend a briefing session to learn about ASD, inclusive strategies, and their role as buddies. Session attendance will be monitored throughout the program for all participants.
Intervention code [1] 314233 0
Treatment: Other
Intervention code [2] 314234 0
Lifestyle
Comparator / control treatment
After enrolling in the study, all children with ASD and their parents will complete a series of face-to-face and questionnaire measures at baseline. Children will then be randomly allocated to either an intervention group or a wait-list control group (comparator). Those allocated to the intervention group will engage in the classical/contemporary AllPlay Dance program during Term 3 2019, while the wait-list control group continues with their usual routine (e.g., any appointments, treatments, or exercise-related activities that do not involve dance). All participants will then repeat the measures they originally completed at baseline. The data collected from the intervention group will be compared against that of the wait-list control group. After this data has been provided, the wait-list control group will have the opportunity to participate in the same classical/contemporary AllPlay Dance program during the following school term (i.e., Term 4 2019).
Control group
Active

Outcomes
Primary outcome [1] 319797 0
Acceptability and feasibility of the study based on general study metrics (e.g., enrollment rates, drop out, session attendance) and participants' subjective report about their experiences of the classical/contemporary AllPlay Dance program.
Timepoint [1] 319797 0
Within 8 weeks of participants completing the dance intervention.
Secondary outcome [1] 369563 0
ASD symptom severity on the Social Responsive Scale – Second Edition (SRS-2)
Timepoint [1] 369563 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [2] 369564 0
Motor Proficiency on the Movement Assessment Battery for Children – Second Edition (MABC-2)
Timepoint [2] 369564 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [3] 369565 0
Emotional and behavioural problems on the Child Behaviour Checklist (CBCL)
Timepoint [3] 369565 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [4] 369566 0
Quality of Life on the Paediatric Quality of Life Inventory (Peds-QL)
Timepoint [4] 369566 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [5] 369567 0
Day-to-Day Executive Functioning on the Behavior Rating Inventory of Executive Function – Second Edition (BRIEF-2)
Timepoint [5] 369567 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [6] 369568 0
Human movement perception abilities on eye-tracking tasks (e.g., perceptual accuracy and gaze patterns on tasks requiring participants to observe and interpret the movements/interactions of point-light figures).
Timepoint [6] 369568 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.
Secondary outcome [7] 369821 0
Walking patterns on motion-sensitive gait tasks (e.g., 'preferred/natural walk' and 'tandem walk').
Timepoint [7] 369821 0
Baseline: Within 8 weeks of the intervention group commencing the dance intervention.
Post-intervention: Within 8 weeks of the intervention group completing the dance intervention.

Eligibility
Key inclusion criteria
For ASD Participants:
• Must be aged between 7 and 12 years old.
• Must have a pre-existing formal diagnosis of ASD.
• Must be able to understand and follow simple verbal and visual instructions.
• Must be available to attend the dance program in Term 3 if randomly allocated to the intervention group.

For Parents of ASD Participants:
• Must be a parent or guardian of a child aged 7-12 with a formal diagnosis of ASD who is enrolled in the study.

For Elite Dancers Participating as Buddies:
• Must be over 14 years of age.
• Must currently be/or have previously completed intensive training in dance.
• Must be interested in pursuing a career as a dancer or a dance teacher.
• Must have a working with children check if they do not qualify for an exemption.
• Must be available to support at least one group of children through the dance program in Term 3 or 4.
Minimum age
7 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For ASD Participants:
• A formal diagnosis of Intellectual Disability (ID).
• Actively participating in a similar dance program in the community on an ongoing basis or enrolled to participate in an external dance program during the study.

For Parents of ASD Participants:
• Non-English speaking - unable to speak/read English at a level sufficient enough to comprehend the study materials (e.g., advertisement flyers, consent forms) and complete the surveys.

For Elite Dancers Participating as Buddies:
• Non-English speaking - unable to speak/read English at a level sufficient enough to comprehend the study materials (e.g., advertisement flyers, consent forms), communicate with the children and complete the surveys.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be encouraged to express their interest in the study by registering their details on the study landing page. A researcher will then contact the participants to confirm eligibility and gather any other important details related to their participation. To enrol in the study, parents of ASD participants will be asked to complete an online consent form to confirm their own involvement and their child’s involvement in the study. The elite dancers/buddies (and their parents for those under 18) will also be asked to complete an online consent form at this point. We will accept up to 40 families with ASD and up to 30 elite dancers/buddies.

Following this, ASD families will complete the baseline assessments (i.e., online survey for parents; face-to-face measures for children with ASD). Elite dancers/buddies supporting children in Term 3 will also be asked to complete a brief online survey and attend a buddy briefing session prior to the program. Once ASD families have completed the baseline measures, children with ASD will be randomly allocated to the intervention group or wait-list control group. Allocation will be concealed by central randomisation. After the first dance program (for the intervention group) is complete, all children with ASD and their parents will be asked to repeat the online survey and face-to-face testing session. The wait-list control group will then participate in the same dance program.

All participants will have the opportunity to provide feedback about their experiences of the program after participating, whether that be in Term 3 (intervention group and their supporting buddies) or Term 4 (wait-list control group and any new supporting buddies).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation schedule will be pre-generated and loaded into the REDCap Online platform by an independent research statistician. The method of randomisation will involve block randomisation (with variable block sizes) and gender stratification.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary aim of this pilot study will be to determine the acceptability and feasibility of the classical/contemporary AllPlay Dance program. This will be assessed using descriptive and qualitative analyses. A secondary aim will be to explore the potential social, cognitive, emotional/behavioural and motor benefits for children with ASD. We intend to conduct general linear model analyses (e.g., repeated measure ANOVAs) to compare the performance of the intervention and wait-list control groups across time. Taking into account Bell et al.’s (2018) recommendations around pilot study sample size, an initial sample of 40 families with ASD (20 intervention, 20 control) is sufficient (and conservative) for the purposes of this pilot study. While the role of the elite dancers/buddies is largely supportive, up to 20 dancers will contribute data to the acceptability/feasibility outcome by providing feedback about their experiences of the program once complete.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/05/2019
Actual
21/05/2019
Date of last participant enrolment
Anticipated
19/10/2019
Actual
19/09/2019
Date of last data collection
Anticipated
9/02/2020
Actual
28/01/2020
Sample size
Target
70
Accrual to date
Final
47
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 302311 0
Other
Name [1] 302311 0
MECCA Brands
Country [1] 302311 0
Australia
Funding source category [2] 302529 0
Charities/Societies/Foundations
Name [2] 302529 0
Emilio and Grace Foundation
Country [2] 302529 0
Australia
Funding source category [3] 302530 0
Other
Name [3] 302530 0
Jonathan and Simone Wenig
Country [3] 302530 0
Australia
Primary sponsor type
Individual
Name
Professor Nicole Rinehart
Address
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country
Australia
Secondary sponsor category [1] 302441 0
None
Name [1] 302441 0
Address [1] 302441 0
Country [1] 302441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302986 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 302986 0
Ethics committee country [1] 302986 0
Australia
Date submitted for ethics approval [1] 302986 0
17/02/2019
Approval date [1] 302986 0
06/03/2019
Ethics approval number [1] 302986 0
2019-061

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92078 0
Prof Nicole Rinehart
Address 92078 0
Deakin Child Study Centre
School of Psychology,
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 92078 0
Australia
Phone 92078 0
+61 (03) 9244 5469
Fax 92078 0
Email 92078 0
[email protected]
Contact person for public queries
Name 92079 0
Ebony Lindor
Address 92079 0
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 92079 0
Australia
Phone 92079 0
+61 3 9246 8468
Fax 92079 0
Email 92079 0
[email protected]
Contact person for scientific queries
Name 92080 0
Ebony Lindor
Address 92080 0
Deakin Child Study Centre
School of Psychology
Deakin University, Melbourne Burwood Campus
221 Burwood Hwy VIC 3125
Country 92080 0
Australia
Phone 92080 0
+61 3 9246 8468
Fax 92080 0
Email 92080 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical limitations.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility and acceptability of AllPlay Dance for autistic children: A pilot randomised controlled trial.2023https://dx.doi.org/10.1016/j.rasd.2023.102271
N.B. These documents automatically identified may not have been verified by the study sponsor.